Expandable member formed of a fibrous matrix having hydrogel polymer for intraluminal drug delivery

Abstract

An intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member including a hydrogel polymer having a therapeutic agent incorporated therein. The hydrogel polymer can be coated on the fiber elements in a co-axial configuration. The fiber elements may also have a second coating including a protective substance surrounding the hydrogel polymer having a therapeutic agent therein. The matrix of fiber elements can be formed by electrospinning. A process of delivering a therapeutic agent to a target site includes providing an intraluminal catheter device having an expandable member formed of a matrix of fiber elements, the expandable member including a hydrogel polymer having a therapeutic agent dispersed therein, and advancing the catheter device at a desired treatment site. Once at the desired treatment site, fluid is introduced into the inflation lumen to expand the expandable member from a first profile to a second profile, and the therapeutic agent is released from the hydrogel polymer and delivered to the desired treatment site.

1. An intraluminal catheter device comprising:
 an elongated catheter shaft having a proximal end portion and a distal end portion, the shaft having an inflation lumen disposed between the proximal end portion and the distal end portion; and 
 an expandable member formed essentially of an electrospun matrix of fiber elements and disposed proximate to the distal end portion of the catheter shaft to define an inner chamber fluidly coupled to the inflation lumen, individual fiber elements of the matrix coated with a hydrogel polymer coating having at least one therapeutic agent incorporated therein. 
 
     
     
       2. The device of  claim 1 , wherein the fiber elements comprise a polymer selected from the group consisting of polyamides, polyurethanes, fluoropolymers, polyolefins, polyimides, polyimines, (methyl)acrylic polymers, polyesters, and co-polymers thereof. 
     
     
       3. The device of  claim 1 , wherein the hydrogel polymer coating having the at least one therapeutic agent incorporated therein completely surrounds the individual fiber elements. 
     
     
       4. The device of  claim 1 , wherein the at least one therapeutic agent is selected from the group consisting of anti-proliferative, anti-inflammatory, antineoplastic, antiplatelet, anti-coagulant, anti-fibrin, antithrombotic, antimitotic, antibiotic, antiallergic and antioxidant compounds and combinations thereof. 
     
     
       5. The device of  claim 1 , wherein the individual fiber elements include a second coating surrounding the hydrogel polymer coating, the second coating comprising a protective substance. 
     
     
       6. The device of  claim 5 , wherein the protective substance is selected from the group consisting of glucose, hydrophilic coatings, mediums which are dissolvable in blood or aqueous mediums, and other mediums which will crack under expansion. 
     
     
       7. The device of  claim 1 , wherein the expandable member is expandable from a first profile to a second profile. 
     
     
       8. The device of  claim 1 , wherein the expandable member is essentially fluid-tight and can maintain an expanded profile. 
     
     
       9. The device of  claim 1 , the expandable member defining an outer surface, and further comprising a coating on at least one portion of the outer surface of the expandable member. 
     
     
       10. The device of  claim 9 , wherein the coating comprises a protective substance. 
     
     
       11. The device of  claim 9 , wherein the coating comprises a hydrogel polymer having at least one therapeutic agent incorporated therein. 
     
     
       12. The device of  claim 11 , further comprising a second coating surrounding the first coating on at least one portion of the outer surface of the expandable member, the second coating comprising a protective substance. 
     
     
       13. The device of  claim 1 , wherein the matrix of fiber elements defines a plurality of gaps between the fibers. 
     
     
       14. The device of  claim 1 , wherein the hydrogel polymer coating having the at least one therapeutic agent incorporated therein partially coats the individual fiber elements. 
     
     
       15. The device of  claim 1 , wherein the at least one therapeutic agent is released from the individual fiber elements upon radial expansion of the expandable member. 
     
     
       16. The device of  claim 1 , wherein the at least one therapeutic agent is released from the individual fiber elements by diffusion upon expansion of the expandable member against a target area. 
     
     
       17. The device of  claim 1 , wherein the at least one therapeutic agent is released from the individual fiber elements within five minutes after expansion of the expandable member. 
     
     
       18. An intraluminal catheter device made by:
 forming an expandable member essentially of an electrospun matrix of fiber elements to define an inner chamber, individual fiber elements of the matrix carrying a hydrogel polymer coating having at least one therapeutic agent incorporated therein; 
 providing an elongated catheter shaft having a proximal end portion and a distal end portion, the shaft having an inflation lumen disposed between the proximal end portion and the distal end portion; and 
 attaching the expandable member to the distal end portion of the elongated catheter shaft with the inner chamber of the expandable member fluidly coupled to the inflation lumen. 
 
     
     
       19. The device of  claim 18 , wherein the individual fiber elements include a second coating surrounding the hydrogel polymer coating, the second coating comprising a protective substance. 
     
     
       20. The device of  claim 18 , wherein the at least one therapeutic agent is released from the individual fiber elements upon radial expansion of the expandable member. 
     
     
       21. The device of  claim 18 , wherein the at least one therapeutic agent is released from the individual fiber elements by diffusion upon expansion of the expandable member against a target area. 
     
     
       22. The device of  claim 18 , wherein the at least one therapeutic agent is released from the individual fiber elements within five minutes after expansion of the expandable member.